Ph3Job Description /h3 ul liCoordinate the preparation, submission, and maintenance of regulatory applications for clinical and non-clinical development programs /li liSupport lifecycle management activities for marketed products, including product information updates and promotional material reviews /li liContribute to the development and implementation of regulatory strategies aligned with business objectives /li liCollaborate closely with cross‑functional teams to integrate regulatory requirements into development and lifecycle plans /li liSupport interactions with regulatory authorities, including preparation of briefing documents and meeting coordination /li liAct as a local regulatory contact for Swissmedic and ensure submissions meet local requirements /li liManage regulatory authority questions, commitments, and responses in collaboration with internal stakeholders /li liMaintain regulatory documentation, submission tracking, and archiving within regulatory systems /li liConduct regulatory research and monitor changes in applicable regulations and guidelines /li liSupport commercial teams during product launches and throughout the product lifecycle by providing regulatory guidance /li /ul h3Requirements /h3 ul liCoordinate the preparation, submission, and maintenance of regulatory applications for clinical and non-clinical development programs /li liSupport lifecycle management activities for marketed products, including product information updates and promotional material reviews /li liContribute to the development and implementation of regulatory strategies aligned with business objectives /li liCollaborate closely with cross‑functional teams to integrate regulatory requirements into development and lifecycle plans /li liSupport interactions with regulatory authorities, including preparation of briefing documents and meeting coordination /li liAct as a local regulatory contact for Swissmedic and ensure submissions meet local requirements /li liManage regulatory authority questions, commitments, and responses in collaboration with internal stakeholders /li liMaintain regulatory documentation, submission tracking, and archiving within regulatory systems /li liConduct regulatory research and monitor changes in applicable regulations and guidelines /li liSupport commercial teams during product launches and throughout the product lifecycle by providing regulatory guidance /li /ul h3Competences /h3 ul liBachelor's degree in Life Sciences, Pharmacy, Biology, Chemistry, or a related scientific discipline /li li3–5 years of experience within Regulatory Affairs in the pharmaceutical industry /li liExperience interacting directly with Swissmedic /li liExperience with Swiss marketing authorisation applications (MAAs) /li liFamiliarity with Swissmedic systems, including the Swissmedic Portal and national publication platform /li liSolid understanding of drug development and the pharmaceutical regulatory environment /li liExperience with lifecycle management and post-approval activities is an advantage /li liStrong stakeholder management and cross‑functional collaboration skills /li liFluent German and English, both written and spoken /li liStrong organisational skills, attention to detail, and the ability to manage multiple priorities in a fast‑paced environment /li /ul h3Job Information /h3 ul liLocation: Basel /li liStart Date: July 2026 /li liDuration: Until December 2026 /li liWorkload: 100% /li /ul /p #J-18808-Ljbffr